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Prediction of Progression of Age-Related Macular Degeneration

Primary Purpose

Macular Degeneration, Macular Degeneration, Wet, Macular Degeneration, Dry

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Algorithm prediction
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Macular Degeneration

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-neovascular AMD at baseline in at least one eye with no signs of GA,
  • > 45 years of age,
  • willingness to participate through a signed consent form.

Exclusion Criteria:

  • Pregnant women and vulnerable populations
  • Participation in an investigational trial that involves treatment with any drug (with the exception of vitamins or minerals) within 3 months prior to Day 1.
  • Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Prediction Algorithm

    Control

    Arm Description

    Patients in the test arm will have a screening visit, then will come for two follow-up visits, at 3 months (if the algorithm determines high-risk of conversion within 3 months) and 6 months.

    Patients in the control arm will have a screening visit, then will come for one follow-up visit, at 6 months (standard care) only.

    Outcomes

    Primary Outcome Measures

    Visual Acuity
    The primary outcome measure will be the difference in visual acuity between test and control patients in those who progressed to late stage AMD

    Secondary Outcome Measures

    Actual risk of conversion
    The actual risk/ of conversion to wet AMD will be calculated for each eye that progressed using regression analysis. This risk will be compared to the risk that the algorithm predicted.
    Number of visits
    Number of visits will be compared between the test arm and the control arm of patients who progression to wet AMD

    Full Information

    First Posted
    October 8, 2020
    Last Updated
    November 17, 2020
    Sponsor
    University of Illinois at Chicago
    Collaborators
    Stanford University, Illinois Retina Associates, Bascom Palmer Eye Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04640649
    Brief Title
    Prediction of Progression of Age-Related Macular Degeneration
    Official Title
    A Novel Approach to Personalized Prediction of Progression of Age-Related Macular Degeneration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2020 (Anticipated)
    Primary Completion Date
    July 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Illinois at Chicago
    Collaborators
    Stanford University, Illinois Retina Associates, Bascom Palmer Eye Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal for this study is to initiate a randomized, controlled clinical trial to test the viability of personalized AMD progression prediction models. Early and intermediate AMD patients will be recruited and randomly assigned them to a control or test group. The test group will include patients who will receive personalized follow-up care based on their predicted risk, and collect baseline and follow-up data. This work will advance the AMD field by improving the identification of high-risk patients as candidates for more frequent screening and earlier treatment, leading to better clinical outcomes.
    Detailed Description
    More than 90% of patients with advanced AMD have severe vision loss. Predicting AMD progression from an early or intermediate stage is crucial, since prompt intervention after a choroidal neovascularization (CNV) event and geographic atrophy (GA) monitoring can greatly improve visual outcomes. Patients at higher risk of progression should have more frequent follow-up visits, since progression often occurs before any visual changes are noticed by the patient. Previous work has determined the risk factors for AMD progression based on drusen features in fundus photos, Optical Coherence Tomography (OCT) and from genetic factors. However, current models are limited by their ability to make predictions over short intervals, which limits their utility in guiding screening intervals. In this study we will recruit patients with early and intermediate AMD in at least one eye who are at risk of converting to wet AMD or GA expansion. We will perform a randomized trial where we will randomly assign them to a control or test group (personalized follow-up care starting at 3 months based on their predicted risk from algorithm results), and collect baseline genetic, demographic, imaging, and clinical data and first follow-up data at the 3 month and 6 month follow-up time points. Outcomes will be measured to determine if an algorithm predicting early follow-up for high-risk patients (3 month) is advantageous over the standard 6 month follow-up time point.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Macular Degeneration, Macular Degeneration, Wet, Macular Degeneration, Dry

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    278 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prediction Algorithm
    Arm Type
    Experimental
    Arm Description
    Patients in the test arm will have a screening visit, then will come for two follow-up visits, at 3 months (if the algorithm determines high-risk of conversion within 3 months) and 6 months.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients in the control arm will have a screening visit, then will come for one follow-up visit, at 6 months (standard care) only.
    Intervention Type
    Other
    Intervention Name(s)
    Algorithm prediction
    Intervention Description
    Patients with early and intermediate AMD in at least one eye who are at risk of converting to wet AMD or GA expansion will be randomly assigned to a test group or control group. The test group will have their baseline data analyzed by an algorithm to predict the probability of conversion to wet AMD. If the probability is high for conversion at or before 3 months, patients will have earlier follow-up care than the control group (standard follow-up care every 6 months).
    Primary Outcome Measure Information:
    Title
    Visual Acuity
    Description
    The primary outcome measure will be the difference in visual acuity between test and control patients in those who progressed to late stage AMD
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Actual risk of conversion
    Description
    The actual risk/ of conversion to wet AMD will be calculated for each eye that progressed using regression analysis. This risk will be compared to the risk that the algorithm predicted.
    Time Frame
    one year
    Title
    Number of visits
    Description
    Number of visits will be compared between the test arm and the control arm of patients who progression to wet AMD
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Non-neovascular AMD at baseline in at least one eye with no signs of GA, > 45 years of age, willingness to participate through a signed consent form. Exclusion Criteria: Pregnant women and vulnerable populations Participation in an investigational trial that involves treatment with any drug (with the exception of vitamins or minerals) within 3 months prior to Day 1. Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joelle A Hallak, PhD
    Phone
    3129960157
    Email
    joelle@uic.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kathleen Romond, MPH
    Email
    kromon2@uic.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joelle A Hallak, PhD
    Organizational Affiliation
    University of Illinois at Chicago
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Prediction of Progression of Age-Related Macular Degeneration

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